Facing TMF Bias: My Role is Not Entry Level PART ONE
I’ve heard your TMF department has a revolving door. Contractors and young, fresh faces constantly churn through their first day on the job and last day in the office. By the time they are proficient, they leave to embrace a new specialty.
This need not be the reality. There is no revolving door where I work. My team has left their TMF bias behind. Where I work, a TMF analyst is not considered a filing clerk or administrative assistant. It is not a “step down” to leave a CRA or project specialist role to pursue management of the TMF.
Most importantly, my team knows my job is not entry level. As an experienced TMF professional, I draw on knowledge gained from hundreds of TMFs to bring a new level of expertise and quality to each clinical trial I am assigned. In the coming weeks, I’ll examine what key attributes a seasoned TMF professional can use to effect change at your organization. In this blog post, I’ll discuss a trait I observe regularly in my most successful TMF colleagues and consider essential to TMF success: a flexible approach to TMF health.
I don’t treat every clinical trial the same.
I know every clinical trial has unique challenges, objectives, and needs – and so does every TMF. Trials in certain therapeutic areas often have assessment-specific and lab-specific documentation. Various trial phases and endpoints can dramatically alter timelines, enrollment, and sponsor expectations. Sponsors may prefer to have me work according to their own workflows, SOPs, or in their own eTMF systems. Having experienced the idiosyncrasies of countless TMFs gives me a foundation of understanding when facing new challenges. It allows me to anticipate the needs of my next assignment and project team without having to take time and resources away from management, my peers, or the job at hand.
I don’t blindly follow existing processes.
I take the time to understand our processes and will speak up if they don’t support our objectives. This means I’m not just filing documents; I’m interpreting them critically. I advocate for the health of the TMF if our current filing structure doesn’t account for study-specific documents or if systematic indexing errors are beginning to accumulate. I take ownership of the TMF quality, not just the completion of my day-to-day tasks. I’m here assist you and the team as we incrementally and continuously improve the health of the TMF. When our processes are aligned with our expectations, the TMF becomes a tool that helps bring the team closer together.
I don’t just check a box.
I unlock the value of the TMF by combining the possibilities of eTMF technology with analytical thinking. When filing a monitoring report, I can retrieve an eTMF report that allows me to compare the monitoring frequency and other visit details against the requirements of the monitoring plan. I can use the dashboard features within the eTMF to group network IRB sites together or compare the completeness of the IRB documents of network sites against those with local IRBs. I don’t just use the TMF reference model and apply metadata because the SOP tells me to; I do it because using the eTMF to its fullest potential allows me to have a powerful impact on the entire lifecycle of a clinical trial.
This pervasive and harmful industry bias—that every TMF role is entry level—undermines us all.
When a TMF fails, patients are left waiting and precious resources are squandered. Why then do we trust something as important as the TMF solely to the inexperienced? And what about those who have dedicated their career to the TMF? We surely cannot solve the industry-wide problem of declining TMF quality without celebrating those who achieve TMF success. If you know someone who adapts to every TMF challenge with resiliency and flexibility, please let them know you appreciate their contribution to the success of your clinical trial. More than fighting TMF bias, you might just inspire the next generation of experienced TMF professionals.
Please check back for our next post in this series discussing how an experienced TMF professional can leverage their confidence and tenacity to end TMF bias and inspire your team to achieve TMF success.